Electrical safety EN 60601-1 / AAMI ANSI ES 60601-1
Is your medical device electrically operated or does it integrate software?
In order to ensure patient safety with regard to electrical risks and risks caused by possible software errors, the requirements of EN 60601-1 / AAMI ANSI ES 60601-1 must be met.
We would be happy to advise you about the correct interpretation of this standard and derive the requirements applicable for your device.
This will enable you to address possible risks linked to the electrical part of the device or device software correctly at the beginning of your development activities and mitigate them through design measures.